Hexabromocyclododecane (HCBD) - Response to Comments

The Consultation Document on the Proposed Risk Management Measure for Hexabromocyclododecane (HBCD) was published on October 3, 2012 for a 60-day electronic public consultation period. Five organizations provided comments: Bromine Science and Environmental Forum (BSEF), Dow Chemicals Canada, Canadian Vehicle Manufacturers’ Association (CVMA), New Brunswick Lung Association and Chemical Sensitivities Manitoba. A Canadian citizen also provided comments.

A summary of comments and responses is included below, organized by topic:

Clarifications and Corrections to the Consultation Document on the Proposed Risk Management Measure

Comment:
The health conclusion should be presented in the Consultation Document.
Response:
The Final Screening Assessment Report concluded that HBCD is not a concern for human health under the Canadian Environmental Protection Act, 1999; therefore, the risk management measure is focused on environmental concerns.

Comment:
The risk management analysis should recognize the inherent toxicity status of HBCD.
Response:
The Final Screening Assessment Report for HBCD was conducted pursuant to section 74 of the Canadian Environmental Protection Act, 1999 and concluded that HBCD meets the criteria under subsection 64(a) of the Canadian Environmental Protection Act, 1999, as it is entering the environment in a quantity or concentration or under conditions that have or may have an immediate or long-term harmful effect on the environment or its biological diversity. This was considered when developing the proposed risk management measure for HBCD.

Comment:
The formal public comment period should be represented as publication plus 60 or 90 days – whichever is applicable.
Response:
The error in the public comment period has been noted.  The public comment period of the proposed Amendments to the Prohibition of Certain Toxic Substances Regulations, 2012 is 75 days and will follow the publication of the proposed Amendments in Canada Gazette Part I as indicated in the Regulations. 

Comment:
The table in Annex A of the Consultation Document should be updated with the results of the 8^th meeting of the POPRC where it was recommended that HBCD be considered for listing to Annex A of the Stockholm Convention at the 6^th meeting of the Conference of the Parties. 
Response:
The information presented in the Consultation Document was accurate at the time of publication in October 2012.

At the 6^th Conference of the Parties to the Stockholm Convention meeting held in May 2013, Parties agreed to list HBCD to Annex A (Elimination) of the Convention with an exemption for expanded (EPS) and extruded (XPS) foam applications in buildings. HBCD was listed to Annex A of the Stockholm Convention in November 2013 and the listing came into force in November 2014.

Risk Management Measures and Objectives

Comment:
Any risk management action undertaken to address the paths where no HBCD is present will not reduce risk.  The risk management should focus where there is an evident risk that needs reduction.
Response:

The risk management objective for HBCD is to achieve the lowest level of release of the substance, which is technically and economically feasible, into the Canadian environment. This is achieved by addressing existing sources of release to the environment, and by preventing new sources of release.  As such, the proposed prohibition addresses 99% of total HBCD use in Canada by prohibiting the substance and expanded polystyrene (EPS) and extruded polystyrene (XPS) foams containing HBCD.    

As outlined in the Toxic Substances Management Policy, the Government of Canada takes into consideration many factors when developing a proposed risk management instrument.  Such factors include: the benefits associated with the use or generation of a substance; the cost and feasibility of developing and using alternatives or remediation; the impact on employment, Canadian competitiveness, trade and regional development; and fairness and equity.

Please refer to the Toxic Substances Management Policy.

Comment:
Associating the Government of Canada’s approach to align the risk management objective of HBCD with considerations to what is technically and economically feasible is very positive.
Response:
The risk management objective for HBCD is to achieve the lowest level of release of the substance, which is technically and economically feasible, into the Canadian environment.

The Government of Canada takes into consideration socio-economic conditions when developing regulatory measures.

Health Assessment

Comment:
When examining the potential for any substance to cause harm, are ultra-low dose health effects, such as endocrine disruption, considered?
Response:
Health effects associated with low and high levels of exposure are assessed and considered in the determination of harm to human health.  All available and relevant data on the potential human health effects are considered in screening assessments.

In the HBCD assessment, endocrine related health effects were selected as the most critical effects to characterize risk. The assessment of long term exposures to HBCD was similar to the approach taken by the European Union (EU RAR 2008) and the Government of Australia (2012), while Health Canada chose a much more conservative approach to assess the risk to children and infants, consistent with our application of precaution as required under the Canadian Environmental Protection Act, 1999.

Please refer to the final Screening Assessment Report for HBCD.

Virtual Elimination List

Comment:
The Government of Canada’s decision to exercise the precautionary principle by adding HBCD to the virtual elimination list although it was concluded that HBCD is not harmful to the health of the general population at current levels of exposure is supported. 
Response:
The final screening assessment report concluded that HBCD meets the virtual elimination criteria set out in subsection 77(4) of the Canadian Environmental Protection Act (CEPA), 1999.

Under CEPA 1999, virtual elimination is the reduction of the quantity or concentration of a toxic substance in releases to the environment to below a "level of quantification" specified by the Ministers.

Prohibiting a toxic substance through regulation is one way of reducing potential releases associated with the manufacture, import, use and sale of the toxic substance and/or products containing the toxic substance.

As outlined in the Consultation Document on the Proposed Risk Management Measure for HBCD (October 2012), the Government of Canada is proposing to implement regulations to prohibit the manufacture, use, sale, offer for sale, and import of HBCD and certain products containing HBCD.  This will be achieved through the addition of HBCD to the Prohibition of Certain Toxic Substances Regulations, 2012.

Prohibition

Comment:
Agreement with the proposed risk management measure for HBCD to implement regulations to prohibit the manufacture, use, sale, offer for sale, import and export of HBCD and products containing HBCD.
Response:
Certain Toxic Substances Regulations, 2012 would add HBCD to the new subsection 7.1in the Prohibition of Certain Toxic Substances Regulations, 2012, thereby prohibiting the manufacture, use, sale, offer for sale or import of the substance HBCD, except for the purpose of manufacturing EPS and XPS foams which would be allowed until December 31, 2016.  The intent of subsection 7.1 is similar to the intent in Schedule 2, Part 2. The proposed Amendments would prohibit EPS and XPS foams containing HBCD used for building or construction applications after December 31, 2016.   

The proposed Amendments would permit the use, sale, and offer for sale of EPS and XPS foams used for building or construction applications that contain HBCD that were manufactured or imported before December 31, 2016.

Comment:
HBCD should be added to Schedule 2, Part 2 of the Prohibition Regulations to allow for its long term use in certain applications. 
Response:
Certain Toxic Substances Regulations, 2012 would add HBCD to the new subsection 7.1in the Prohibition of Certain Toxic Substances Regulations, 2012, thereby prohibiting the manufacture, use, sale, offer for sale or import of the substance HBCD, except for the purpose of manufacturing EPS and XPS foams which would be allowed until December 31, 2016.  The intent of subsection 7.1 is similar to the intent in Schedule 2, Part 2. The proposed Amendments would prohibit EPS and XPS foams containing HBCD used for building or construction applications after December 31, 2016.   

The proposed Amendments would permit the use, sale, and offer for sale of EPS and XPS foams used for building or construction applications that contain HBCD that were manufactured or imported before December 31, 2016.

Comment:
It would be prudent to prohibit the manufacture, use, sale, import and export of HBCD sooner than December 31, 2016.
Response:
The Government of Canada agrees that a risk management instrument for HBCD should be implemented as quickly as practical.  In light of this, and based on information submitted by stakeholders, the proposed temporary exemptions will provide time for industries to phase out the use of HBCD and transition to alternative substances.

Alternatives and Phase-Out Considerations

Comment:
The government of Canada should exercise care in stating that alternatives exist for all uses of HBCD as subsequent information and data may emerge.
Response:
The Government of Canada is continuing to engage stakeholders throughout the development of the proposed Regulations.  There will be a 75-day public comment period following the publication of the Regulations Amending the Prohibition of Certain Toxic Substances Regulations, 2012, and stakeholders are encouraged to provide comment or information, including the status of alternatives, during this time.

Comment:
The government of Canada should indicate if suitable HBCD alternatives are currently being assessed in Canada and if this work could be completed before the regulation comes into force.
Response:
Environment Canada has assessed one alternative to HBCD through its New Substances Program and concluded that the alternative is non-toxic.  Additional alternatives may be assessed as part of the Chemicals Management Plan as required.

The Certain Organic Flame Retardants Substance Grouping has been created to assess a series of organic flame retardants in a more holistic manner. The final assessment conclusions for this grouping are expected by Spring 2016.

For further information, please refer to the Certain Organic Flame Retardants Substance Grouping web page on the Chemicals Substances website.

Comment:
The study “Socio-economic analysis of usage restriction of brominated flame retardant HBCD” completed by the Graduate School of Environment and Information Sciences, Yokohama National University, Japan estimates an increase in building material cost when using an alternative (Tetrabromocyclooctane, CAS #3194-57-8) in place of HBCD.
Response:
As part of the Cabinet Directive on Regulatory Management, a Costs and Benefits analysis is conducted for regulatory measures such as the proposed prohibition of HBCD. An estimated cost increase to use an alternative substance was taken into consideration.

Exemptions

Comment:
The Government of Canada should be prepared to grant exemptions for other uses of HBCD.  The ability to grant exemptions should be allowed domestically but also managed within the international processes.
Response:
The Government of Canada takes into account domestic and international considerations when proposing risk management measures such as time-limited exemptions for prohibited substances.

The Government of Canada is continuing to engage stakeholders throughout the development of the proposed Regulations.  There will be a 75-day public comment period following the publication of the Regulations Amending the Prohibition of Certain Toxic Substances Regulations, 2012, and stakeholders are encouraged to provide comments or information, including other uses for HBCD, during this time.

Comment:
The Government of Canada should allow the use of HBCD to enable the polystyrene foam insulation industry to continue manufacturing and supplying essential insulation products until commercially-scaled production and capacity for suitable alternatives to HBCD exist in the marketplace, and to allow for existing supply chain inventory depletion when establishing the coming into force of the Regulations.
Response:
The proposed Amendments to the Prohibition of Certain Toxic Substances Regulations, 2012 would prohibit the manufacture, use, sale, offer for sale or import of the substance HBCD, except for the purpose of manufacturing EPS and XPS foams which would be allowed until December 31, 2016.  The proposed Amendments would allow expanded polystyrene (EPS) and extruded polystyrene (XPS) foams containing HBCD used for building and construction applications until December 31, 2016.

The proposed Amendments would also permit the use, sale, and offer for sale of EPS and XPS foams used for building or construction applications that contain HBCD that were manufactured or imported before December 31, 2016.

The proposed temporary permitted use for EPS and XPS foams used for building or construction applications that contain HBCD is expected  to allow stakeholders adequate time to phase out HBCD use and transition to alternatives while still managing potential environmental risks.

Comment:
The Government of Canada should not apply a time limit to the proposed exemption for service, legacy, replacement and warranty parts for automobiles.  Having no time limit would allow customers to continue to obtain service components for the life of their vehicle.
Response:
Through consultations, the automotive sector provided information on the progress it has made to phase-out HBCD. This sector now represents less than 1% of HBCD use in Canada and is being phased out globally in automotive applications. The risk management measures included in the consultation document proposed a time limited regulatory exemption on the use of HBCD within the automotive sector. The sector expressed concern regarding its ability to fully phase out HBCD in the near-term due to the complexity of its operations. Environment Canada has acknowledged these concerns and will address the use of HBCD in the automotive sector through other measures to work towards achieving a full phase-out. This approach allows the flexibility required to support the competitiveness of the sector in an integrated North American automotive manufacturing industry.  Therefore the use of HBCD within the automotive sector would not be included within the proposed Amendments.

Comment:
The time-limited exemption for service, legacy, replacement and warranty parts for automobiles is too long.  It should not extend beyond a year after the regulations come into force.
Response:
Through consultations, the automotive sector provided information on the progress it has made to phase-out HBCD. This sector now represents less than 1% of HBCD use in Canada and is being phased out globally in automotive applications. The risk management measures included in the consultation document proposed a time limited regulatory exemption on the use of HBCD within the automotive sector. The sector expressed concern regarding its ability to fully phase out HBCD in the near-term due to the complexity of its operations. Environment Canada has acknowledged these concerns and will address the use of HBCD in the automotive sector through non-regulatory measures to work towards achieving a full phase-out. This approach allows the flexibility required to support the competitiveness of the sector in an integrated North American automotive manufacturing industry.  Therefore the use of HBCD within the automotive sector would not be included within the proposed Amendments.

Comment:
The proposed time-limited exemption applicable to automobiles and automobile parts is supported.
Response:
Through consultations, the automotive sector provided information on the progress it has made to phase-out HBCD. This sector now represents less than 1% of HBCD use in Canada and is being phased out globally in automotive applications. The risk management measures included in the consultation document proposed a time limited regulatory exemption on the use of HBCD within the automotive sector. The sector expressed concern regarding its ability to fully phase out HBCD in the near-term due to the complexity of its operations. Environment Canada has acknowledged these concerns and will address the use of HBCD in the automotive sector through non-regulatory measures to work towards achieving a full phase-out. This approach allows the flexibility required to support the competitiveness of the sector in an integrated North American automotive manufacturing industry.  Therefore the use of HBCD within the automotive sector would not be included within the proposed Amendments.

Comment:
The final regulation should have an exemption for the public, to products already in use by the public or alternatively not apply to the general public.
Response:
The proposed Amendments to the Prohibition of Certain Toxic Substances Regulations, 2012 include an exemption for other products containing HBCD that were manufactured or imported prior to the coming into force of the proposed Amendments. 

This is intended so that products which are already in use on the date that the regulations come into force , including those used by the public, will not be subject to the proposed Regulations. 

Waste Management

Comment:
The proposed risk management measure should adequately address the safe removal and subsequent disposal of HBCD containing materials, as well as prohibit the use of materials containing HBCD in the recycled stream. 
Response:
Under the Chemicals Management Plan, HBCD and other substances are being monitored at certain landfills to determine concentrations in landfill leachate. This information will contribute to a determination of whether additional risk management actions are warranted for HBCD.

The Basel Convention is developing guidelines for the environmentally sound management of wastes containing brominated flame retardants, including HBCD. Thresholds for acceptable concentration of these contaminants in the recycled stream and other waste management methods have yet to be established. 

International Considerations

Comment:
The Government of Canada should align its domestic restrictions on HBCD, including timelines and phase-out schedules, with international measures such as those of the Stockholm Convention, the Registration, Evaluation, Authorisation and Restriction of Chemical substances  (REACH) program in the European Union, and the United States.
Response:
The Government of Canada seeks to align its domestic regulatory measures with international regulatory initiatives whenever practical and feasible, while taking into consideration the Canadian context.

The Government of Canada recognizes the importance of cooperation with other jurisdictions when proposing risk management initiatives for substances that are used and managed globally such as HBCD. 

Canada has also been working with international partners to support global alignment of restrictions imposed on HBCD. 

Cooperation with other jurisdictions is achieved through a number of avenues including participation in the Consultation on Substance Management (COSM) forum between Canada and the United States which is intended to better align the two countries’ regulatory approaches, where possible.  The Sound Management of Chemicals (SMOC) working group is an initiative under the Commission for Environmental Cooperation (CEC) and provides a framework for regional cooperation for the sound management of the full range of chemical substances of mutual concern throughout their life cycles.  The Government of Canada has also established a Memorandum of Understanding with the European Chemical Agency (ECHA) to facilitate information exchange on the regulation of substances.

Comment:
The Government of Canada should exercise caution in directly adopting the US EPA Design for the Environment initiative as various program elements may not be.
Response:
The Government of Canada seeks to align its domestic regulatory measures with international regulatory initiatives whenever practical and feasible, while taking into consideration the Canadian context.

The Government of Canada recognizes the importance of cooperation with other jurisdictions when proposing risk management initiatives for substances that are used and managed globally such as HBCD. 

Canada has also been working with international partners to support global alignment of restrictions imposed on HBCD. 

Cooperation with other jurisdictions is achieved through a number of avenues including participation in the Consultation on Substance Management (COSM) forum between Canada and the United States which is intended to better align the two countries’ regulatory approaches, where possible.  The Sound Management of Chemicals (SMOC) working group is an initiative under the Commission for Environmental Cooperation (CEC) and provides a framework for regional cooperation for the sound management of the full range of chemical substances of mutual concern throughout their life cycles.  The Government of Canada has also established a Memorandum of Understanding with the European Chemical Agency (ECHA) to facilitate information exchange on the regulation of substances.

Export Control List

Comment:
The Government of Canada should conduct separate consultations on the addition of HBCD to the Export Control List, and should consider aligning the addition with the coming into force of the HBCD prohibitions domestically.
Response:
Canada has a deliberate process for ratifying the listing of a chemical to the Stockholm Convention.  Prior to considering the ratification of HBCD, Canada will implement action(s) domestically as required to comply with the obligations under the Convention. 

Canada will be in a position to consider ratification  ofthe listing of HBCD to the Stockholm Convention when the current uses of HBCD have been phased out.  The need for export controls for HBCD (either regulatory or administrative) will be examined. Furthermore, the need for separate consultations will be examined and may be undertaken on the proposed addition of HBCD to the Export Control List (Schedule 3 of CEPA 1999) at a future date. 

The Basel Convention controls the transboundary movement of hazardous wastes and their disposal. Wastes consisting of, containing or contaminated with HBCD are subject to the provisions of the Basel Convention.  Exports or imports of such wastes can be allowed under the Basel Convention if the prior informed consent procedure is followed.

Comment:
Products or waste containing HBCD should not be exported to other countries.
Response:
Canada has a deliberate process for ratifying the listing of a chemical to the Stockholm Convention.  Prior to considering the ratification of HBCD, Canada will implement action(s) domestically as required to comply with the obligations under the Convention. 

Canada will be in a position to consider ratification  ofthe listing of HBCD to the Stockholm Convention when the current uses of HBCD have been phased out.  The need for export controls for HBCD (either regulatory or administrative) will be examined. Furthermore, the need for separate consultations will be examined and may be undertaken on the proposed addition of HBCD to the Export Control List (Schedule 3 of CEPA 1999) at a future date. 

The Basel Convention controls the transboundary movement of hazardous wastes and their disposal. Wastes consisting of, containing or contaminated with HBCD are subject to the provisions of the Basel Convention.  Exports or imports of such wastes can be allowed under the Basel Convention if the prior informed consent procedure is followed.

One-for-One Rule

Comment:
The Government of Canada should conduct specific consultations and present more explicit discussions on the “One for One” Rule as applied to this regulatory initiative.
Response:
The “One-for-One” rule would apply to the proposed Amendments, as there would be incremental administrative costs on business. Administrative costs for businesses would include the need to learn about the new regulatory requirements. Moreover, the laboratories would be required to submit annual reports in certain circumstances. Following Treasury Board Secretariat’s guidance on standard costing, the annualized administrative cost of these activities has been calculated. The Regulatory Impact Analysis Statement includes a section on the “One for One” Rule as it applies to the proposed Amendments to the Prohibition of Certain Toxic Substances Regulations, 2012.  The cost estimate is considered reasonable based on the nature and complexity of the administrative requirements.

Date modified:

2016-06-28